ClearanceBrief
Recall Z-0210-2009 ยท GIO Tube, Collection, Capillary Blood

Drummond Scientific Co

Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

DateNov 7, 2008 (initiated Aug 1, 2008)
StatusTerminated
Reasonpresence of OSCS contaminant
Root causeMaterial/Component Contamination
ActionThe recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
Quantity1000 vials
DistributionNationwide Distribution --- including states of FL and MA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.